The opioid epidemic is a public health crisis impacting communities, schools and families. During our session, we’ll discuss the risks associated with opioid misuse and the NJ laws that are in place to reduce risk, accumulation, and side effects associated with opioid prescription pain management. You will also learn how health care providers are working to improve the current crisis with new protocols and safe and effective non-opioid pain management alternatives.

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Gaining Perspective on the Opioid
Epidemic
Laura Balsamini, Pharm.D., BCPS
National VP of Pharmacy Services
Summit Medical Group, NJ
June 18th, 2019

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Objectives
• The opioid epidemic is a public health crisis impacting communities,
schools and families.
• During our session, we’ll discuss the risks associated with opioid
misuse and the NJ laws that are in place to reduce risk,
accumulation, and side effects associated with opioid prescription
pain management.
• You will also learn how health care providers are working to improve
the current crisis with new protocols and safe and effective non-
opioid pain management alternatives.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Life is about choices

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Scope of the Problem

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
How Did We Get Here?
• 1804: morphine distilled from opium
• 1898: chemist at Bayer invents heroin
• 1960: Valium is the first $100 million drug on the market
• 1980’s: Mexican Black Tar Heroin in San Francisco
• 1986: Foley and Portenoy publish paper in Journal of
Pain that Opioids are safe to use for acute pain.
• 1990’s: Black Tar Heroin expands all over the US
• 1996: Dr. David Proctor’s Pill Mill Clinic Established
• 1996: Purdue released and markets OxyContin
• 1998: VA and JCAHO urge doctors to treat Pain as the
5th Vital Sign
• 2007: Purdue sued for $634 million
• 2008: Opioid/Heroin Drug Overdoses the leading cause of
death

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
29%
increase in
NJ

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
NJ CARES

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
• Papaver somniferum also known as opium poppy is the flowering plant which
contains natural opium alkaloids including morphine, codeine, and thebaine.
• Semi-synthetic opioids: manmade using natural alkaloids.
– Examples: oxycodone, hydrocodone, hydromorphone, oxymorphone,
and heroin.
• Fully synthetic opioids: completely manmade in a lab.
– Examples: tramadol, methadone, fentanyl, tapentadol, butorphanol, and
meperidine.
• United States’ Drug Enforcement Agency (DEA) classifies drugs or chemicals
into five “schedules”
• Depends on the drug’s acceptable medical use & abuse/dependency
potential.
• Schedule 1:
– No medical indication of use per federal law
– High potential for abuse
– High potential to create severe psychological & physical dependence
– Examples: Heroin, marijuana, and ecstasy
• Schedule 5:
– Least potential for abuse
– Least potential to create severe psychological & physical dependence
– Example: Vicodin AC (Codeine syrups)
What are opioids?

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
National Drug Overdose Deaths Involving
Benzodiazepines, by Opioid Involvement,
Number Among All Ages, 1999-2017
Source: : Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death
1999-2017 on CDC WONDER Online Database, released December, 2018
1,135
4,500
11,537
0
5,000
10,000
15,000
20,000
25,000 Benzodiazepines
Benzodiazepines and Any Opioid
Benzodiazepines Without Any Opioid
Benzodiazepines and Other Synthetic Narcotics

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Preventing Harm

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Opioid
Stewardship
Safe Prescribing
Saves Lives

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
THE CDC GUIDELINE FOR PRESCRIBING
OPIOIDS FOR CHRONIC PAIN
• The CDC issued recommendations for treating adults with chronic
pain in outpatient settings
• The guidelines do not apply to patients receiving cancer treatment,
palliative care, or end-of-life care.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Safe Prescribing: MORPHINE MILLIGRAM
EQUIVALENTS (MME)
50 MME/day 90 MME/day
Dose # of tablets Dose # of tablets
50 mg of
hydrocodone
10 tablets of
hydrocodone/APAP
5/325 mg
90 mg of
hydrocodone
9 tablets of
hydrocodone/APAP 10/325
mg
33 mg of
oxycodone
~2 tablets of oxycodone
sustained-release 15 mg
60 mg of
oxycodone
~2 tablets of oxycodone
sustained-release 30 mg
12 mg of
methadone
<3 tablets of methadone
5 mg
~20 mg of
methadone
4 tablets of methadone 5 mg
APAP = acetaminophen
• Thinking twice before taking ≥ 50 MME/day  DOUBLES risk of overdose
• Avoid increasing ≥ 90 MME/day  INCREASES risk of DEATH due to overdose
• Have naloxone on hand if taking ≥ 50 MME/day
• Avoid concomitant use of opioids and benzodiazepines (FDA Black Box Warning)
• When necessary, ensure minimum dose/duration

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What the payers say?
• Prior Authorization (PA)
• Certain insurance drug plans require PA for any patient receiving
≥ 90 MME/day
• Quantity or Day Supply Limits
• Insurance may limit days supply for opioids and benzodiazepines
• Drug Utilization Review at Point of Sale
• Require clinical discussion or dialogue between dispensing
pharmacist and prescribing physician before dispensing
medication

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Reducing Dose (Tapering)
• When the benefits of continuing high doses of opioid outweigh the
risks, dose reduction is considered.
• Duration or speed of tapering is individualized to each patient.
• Additional medications should be prescribed to mitigate withdrawal
symptoms with reducing opioid therapy.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Treating Opioid Use Disorder

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
• Dopamine secretion in the primitive brain is trigger for our primary reward
system
• Secretion happens when:
– We eat a good meal
– We fall in love
– We have sex
– We consume certain drugs

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Dopamine Levels
Methamphetamine
Heroin
Marijuana
(THC)
Best day
ever
Baseline

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Dopamine and Drugs
• Drugs drastically increase dopamine levels
• With repeated use, brain adapts and down regulates secretion of natural
dopamine
– Leading to dopamine deficiency!!
Baseline
New Baseline with
chronic drug abuse

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Opioid Use Disorder (OUD)
• Substance use: the use, even one time, of any substance
• Substance misuse: the use of any substance in a manner, situation,
amount or frequency that can cause harm to users or to those around
them
• Substance Use Disorder (SUD): medical illness caused by repeated
misuse of a substance or substances.
– Develops slowly overtime due to changes in the brain
– Impacts social function and health
• Addiction: most severe form of SUD
– Compulsive use of one or more substance
– Chronic, relapsing brain disease
– Potential for recovery and relapse

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Medication Assisted Treatment (MAT)
• Medicated-Assisted Treatment (MAT)
– Use of FDA-approved medications with counseling and
behavioral therapies to treat opioid use disorders.
– Augments dopamine levels with medications.
– Allows the brain to “re-set” so that behavioral therapy can be
effective.
– MAT is not trading one addiction for another. It is not fighting fire
with fire!
• https://njsams.rutgers.edu/dastxdirectory/txdirmain.htm

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Medication Assisted Treatment (MAT)
• There are four medications commonly used to
treat opioid addiction:
– Methadone
• Tablet and suspension
– Naltrexone (Revia and Vivitrol)
• Tablet or injection
• Must be used after being opioid free
– Buprenorphine (Subutex)
• Dissolving tablet or cheek film
• 6 month implant under the skin
• Must be used after being opioid free
– Buprenorphine and naloxone (Suboxone)
• Dissolving tablet or cheek film
• Must be used after being opioid free

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
MAT Centers

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
• Naloxone, antidote.
• In New Jersey, Pharmacists are permitted by
law to dispense naloxone in any form to a
patient or caretaker of a patient who is at risk
of opioid overdose pursuant to a standing
order.
• Standing orders are issued by the Department
of Health to individual Pharmacists or
Pharmacy chains.
Overdose Reversal

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
• Drug Take-Back
Locations:
– https://apps2.deadiv
ersion.usdoj.gov/pub
dispsearch/spring/m
ain?execution=e1s1
• FDA Flush List:
– https://www.fda.gov/me
dia/109643/download
• Dispose in Household
Trash:
– https://www.fda.gov/dru
gs/safe-disposal-
medicines/disposal-
unused-medicines-
what-you-should-
know#Disposal

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Pain Management

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Non-Opioid Pain Medications
Acetaminophen
Tylenol
NSAIDS
Ibuprofen (Motrin,
Advil)
Naproxen (Aleve)
Meloxicam (Mobic)
Topicals: Diclofenac
gel
Anticonvulsants
Gabapentin
(Neurontin)
Pregabalin
(Lyrica)
Antidepressants
Duloxetine
(Cymbalta)
Nortriptyline (Elavil)
Venlafaxine (Effexor)
Muscle relaxants
Baclofen
Cyclobenzaprine
(Flexeril)
Carisoprodol
(Soma)
Anesthetics
Lidocaine gel
or patch
Corticosteroids
Prednisone

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Non-pharmacological Pain Management
• Yoga
• Tai chi
• Massage
• Manipulation
• Mindfulness
• Music therapy
• Aroma Therapy
• Pranic Healing
• Heat and Cold
• Acupuncture

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Interventional Pain Management
Pre and post-
operative nerve
block procedures

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by SHM and content may not be reproduced, downloaded, disseminated, published or transferred in any form or by any means except with prior written permission of SHM.
Questions?